CANNULATED DEVICE REPROCESSING; FDA workshop feedback

Large numbers of different instruments, confusing manufacturer’s instructions and instrument design are just a few of the reasons put forward to explain incidences of inadequately reprocessed instruments in US healthcare facilities according to speakers at the FDA public workshop that took place in June. Speaking on behalf of healthcare facilities, Linda Condon, Director of Sterile Processing at Johns Hopkins University Hospital, Baltimore, MD noted that 14,000 different instruments can pass through her department in any one day, and asked “how do you manage instrument reprocessing for all of these?” Condon called for the standardization of manufacturer’s instructions in order to overcome the daily challenges, including time constraints, staffing issues and a lack of co-ordination between the OR and Central Sterile Services. Over the two day event, speakers from industry, clinicians and sterile processing personnel underlined areas for improvements on reprocessing guidelines, with the consequences exemplified by reports of adverse patient outcomes and the damage they can cause to the reputation of the physician and the hospital. Melissa Schaefer from the Centers for Disease Control and Prevention (CDC) acknowledged the difficulties in linking outcome measures such as Healthcare-Acquired Infection rates with reprocessing problems and asked the question “How many lapses in reprocessing do we not hear about?” According to Sheila Murphey, MD, from the Infection Control Devices Branch (FDA) some device designs ‘thwart’ reprocessing, noting problems with debris accumulation and difficulties in cleaning devices with channels where the manufacturer fails to identify appropriate cleaning agents and accessories. Steve Turtil from the FDA’s Center for Design of Devices reiterated this, drawing attention to a device with a hidden lumen, where the manufacturer’s instructions showed no detail of disassembly for cleaning. Manufacturer’s design and their reprocessing instructions weren’t the only group to blame, as was acknowledged by keynote speaker Dr. Michelle McMurry-Heath, FDA “The end users just aren’t doing what they are supposed to be doing” with regards to following reprocessing best practices. The workshop identified the need for relevant stakeholders, including government agencies, manufacturers and healthcare providers to communicate and collaborate on standards and guidelines for the reprocessing of medical devices. To address the highlighted issues, the FDA will work with standards-setting groups to develop and update processes, validation test methods, designs and acceptance criteria for cleaning reusable medical devices. UK based Single Use Surgical Ltd offers an alternative to reprocessing instruments with narrow channels. They supply a wide range of disposable suction tube instruments for use in surgical procedures across several specialties. The company’s focus on high quality, ergonomic design and customer support provides hospitals with a cost-effective alternative to reprocessing devices that carry a risk of being inadequately cleaned due to instrument design and inappropriate manufacturer’s instructions. Switching to single use also reduces the volume of difficult to clean devices that pass through the Central Sterile on a daily basis, helping to alleviate time constraints and ultimately to reduce Hospital-Acquired Infection rates. Source: medlatest staff writer